(80 days)
Not Found
No
The description focuses on standard RF energy delivery and temperature control based on user settings and feedback, without mentioning any AI/ML algorithms for decision-making, pattern recognition, or adaptive learning.
Yes
The device is used for the "coagulation of blood vessels during general surgery," which is a treatment intended to manage or alleviate a medical condition.
No
Explanation: The device is indicated for use in the "coagulation of blood vessels during general surgery," which is a treatment or surgical procedure, not a diagnostic one. Its components further describe its function in delivering and controlling RF energy for treatment.
No
The device description clearly outlines multiple hardware components: a probe, an RF generator, an instrument cable, and an optional footswitch. While the RF generator is software-controlled, the system is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation of blood vessels during general surgery." This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device description details components used to deliver RF energy for coagulation. There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as reagents, sample handling procedures, or analytical methods for detecting substances or characteristics in a sample.
Therefore, the VNUS Closure™ System is a surgical device used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VNUS Closure™ Catheter System is intended for use in the coagulation of blood vessels during general surgery.
Product codes
GEI
Device Description
The VNUS Closure™ System consists of three main components: The VNUS Closure Probe, the VNUS RF Generator and the VNUS Instrument Cable. The Closure Probe is provided Sterile, and is a single-use, disposable device. The RF Generator is non-sterile. The Instrument Cable is autoclave sterilized by the user. An optional Footswitch for RF ON/RF OFF is provided for use at the physician's discretion.
The RF Generator is a high frequency electronic, bipolar, software controlled instrument. It allows the user to set Power, Temperature and Time values, and provides user displays of Power. Temperature and Time (setpoints and measured values) as well as measured impedance and other messages. The RF Generator works in a temperature controlled, power limited manner, based on operator settings and temperature feedback provided by a thermocouple in the Closure Probe.
The Closure Probe is used to carry RF energy to the desired treatment site and provide temperature feedback to the RF Generator. It is designed to deliver the RF energy in a bipolar manner.
The Instrument Cable is used to connect the Closure Probe to the RF Generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical tests performed by VNUS have demonstrated the substantially equivalent performance of the Closure System with predicate electrosurgery systems used for substantially equivalent indications.
Key Metrics
Not Found
Predicate Device(s)
K971532, K972350, K971711, K964143, K972299, K964736, K971341
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Summary of Safety and Effectiveness
- Determination of Substantial Equivalence A. VNUS Closure™ System
FEB 2 0 1998
в. Common Name
Electrosurgery System/Electrosurgical Coagulator
C. Predicate Device(s)
ArthroCare Electrosurgery System (K971532) Boston Surgical Products, Inc. Model 50 Bipolar Coagulator (K972350) Somnus Model 215 Electrosurgical Generator and Accessories (K971711) Valley Forge Scientific Mini-Symm Bipolar Coagulator (K964143) Bergen Model 500 Electrosurgery Generator (K972299) Bergen 610 Coagulator (K964736) Kirwan 28 1000 Coagulator (K971341)
D. Device Description
The VNUS Closure™ System consists of three main components: The VNUS Closure Probe, the VNUS RF Generator and the VNUS Instrument Cable. The Closure Probe is provided Sterile, and is a single-use, disposable device. The RF Generator is non-sterile. The Instrument Cable is autoclave sterilized by the user. An optional Footswitch for RF ON/RF OFF is provided for use at the physician's discretion.
The RF Generator is a high frequency electronic, bipolar, software controlled instrument. It allows the user to set Power, Temperature and Time values, and provides user displays of Power. Temperature and Time (setpoints and measured values) as well as measured impedance and other messages. The RF Generator works in a temperature controlled, power limited manner, based on operator settings and temperature feedback provided by a thermocouple in the Closure Probe.
The Closure Probe is used to carry RF energy to the desired treatment site and provide temperature feedback to the RF Generator. It is designed to deliver the RF energy in a bipolar manner.
The Instrument Cable is used to connect the Closure Probe to the RF Generator.
ய் Intended Use
The VNUS Closure™ Catheter System is intended for use in the coagulation of blood vessels during general surgery.
This premarket notification is being submitted as the VNUS Closure System is a new device. Electrosurgical Coagulation Devices and Accessories are Class 2 per 21 CFR 878.4400.
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F. Intended Use of Predicate Devices
The specified predicate devices are indicated for "soft tissue resection", "soft body tissue coagulation", "the coagulation of tissue", and/or for "ablation and coagulation of blood vessels during general surgical procedures."
Technological Comparison G.
The technological characteristics and principals of operation of the VNUS Closure System are substantially equivalent to the noted predicate devices. All devices rely on the delivery of RF energy to achieve their intended use.
H. Discussion of Non-Clinical Tests and Conclusions
Non-clinical tests performed by VNUS have demonstrated the substantially equivalent performance of the Closure System with predicate electrosurgery systems used for substantially equivalent indications.
.. Summary of Safety and Effectiveness
Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-ciinical testing performed by VNUS, it is concluded that the Closure System is substantially equivalent to the noted predicate devices in safety and effectiveness.
Tom M. Holdych
Vice President, Regulatory and Clinical Affairs VNUS Medical Technologies, Inc. December 1, 1997
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles facing to the right. The profiles are black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 1998
Mr. Tom Holdych Vice President, Regulatory and Clinical Affairs VNUS Medical Technologies, Inc. 238 East Caribbean Drive Sunnyvale, California 94089
Re: K974521 VNUS™ Closure™ System Trade Name: Regulatory Class: II Product Code: GEI Dated: December 1, 1997 December 2, 1997 Received:
Dear Mr. Holdych:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act · include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with most with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Holdych
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your . . device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Ph.D., M.D. a M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: Closure™ System
510(k) Number (if known):
974521
Indications for Use:
The VNUS Closure™ System is indicated for use in the coagulation of blood vessels during general surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CORH, OFFICE OF DEVICE EVALUATION (ODE)
Over the Counter Use: (Per 21 CFR 801.109)
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or
Prescription Use:
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